SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Scholl Athlete’s Foot Spray Liquid

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Tolnaftate 0.068%w/w (to deliver 1% to the skin).

Excipient: Butylhydroxytoluene (E321) 0.007% w/w

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Topical spray

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Prevention and treatment of Athlete’s Foot

4.2 Posology and method of administration

Topical

For best results the feet should be washed and dried before use. Shake can before use. Point nozzle towards the affected area, holding it 10-15cm away. Spray liberally over the affected area.

Recommended Dose: Twice daily, in the morning and at night.

Treatment should continue for up to two weeks after the symptoms disappear.

No distinction is made between different categories of patient.

4.3    Contraindications

Not recommended for nail or scalp infections.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4    Special warnings and precautions for use

For external use only Keep out of eyes

If symptoms do not improve within 10 days, discontinue use and consult your doctor.

Flammable, pressurised container. Protect from direct sunlight and do not expose to temperatures exceeding 50°C. Do not spray on naked flame or incandescent material. Do not pierce or burn even after use.

Contains butylhydroxytoluene (E321). May cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Pregnancy and lactation

No known restrictions.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Adverse reactions have been ranked under headings of frequency using the following convention:
Very common	> 1/10
Common	> 1/100 to > 1/10
Uncommon	> 1/1,000 to < 1/100
Rare	> 1/10,000 to < 1/1,000
Very rare	<1/10,000
Within easy frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System Organ Class	Frequency
Skin and subcutaneous tissue disorder	Unknown	Skin reactions Skin irritation Pruritis Contact dermatitis

4.9 Overdose

Not applicable.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Antifungal

5.2 Pharmacokinetic properties

Not applicable for a topical dosage form.

Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butylated Hydroxytoluene

Polyethylene - polypropylene glycol monobutyl ether

Ethanol

Butane

Propane

Iso-butane

6.2 Incompatibilities

None stated.

6.3 Shelf life

48 months unopened.

6.4 Special precautions for storage

Warnings for the labelling:

Pressurised container: May burst if heated.

Keep away from heat/sparks/open flames/hot surfaces. - No smoking.

Do not spray on open flame or other ignition source.

Pressurised container: Do not pierce or burn, even after use.

Protect from sunlight. Do not expose to temperatures exceeding 50° C / 122° F. Danger. Extremely Flammable Aerosol (and logo)

6.5 Nature and contents of container

Tinplate aerosol can, epoxy coated internally with valve assembly and overcap. Can sizes: 150ml.

Special precautions for disposal

None stated

7 MARKETING AUTHORISATION HOLDER

Scholl Consumer Products Ltd

103-105 Bath Road

Slough

SL1 3UH

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 00587/0008

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

24/04/85 / 29/01/99

10 DATE OF REVISION OF THE TEXT

18/02/2015